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Inflatable Bone Tamps
EUDAMEDClass IIa (EU MDR)
Ref A500032Model Vertexpand-3Ref A500003Model Vertexpand-1Ref A500002
Identity
- Device Name
- Inflatable Bone Tamps EUDAMED
- Model / Reference
- Vertexpand-3 EUDAMEDA500032 EUDAMEDVertexpand-1 EUDAMEDA500003 EUDAMEDA500002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974754671127 EUDAMED06974754671080 EUDAMED06974754671073 EUDAMED
- Basic UDI-DI
- B-06974754671127 EUDAMEDB-06974754671080 EUDAMEDB-06974754671073 EUDAMED
- EMDN Code
- P091399 ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Joint prosthesis implantation kit, single-use
Inflatable Bone Tamps by Beijing Bonsci Technology Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06974754671127 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Beijing Bonsci Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000013535
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (3)
- EUDAMED edfa140c-c8f8-4f9d-b940-33f9e00db951 61 fields · synced Jul 21, 2026
- EUDAMED 9c928120-e8e3-4960-ac90-fb34c180fb2d 61 fields · synced May 17, 2026
- EUDAMED dbf7c98a-27cc-40e4-babc-0f09fd2f319e 61 fields · synced May 19, 2026